Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months

NCT04491773 | Completed

• 1 other identifier: 1516/19
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months

  Changes in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density

  More than 6 months

Study Arms (2)

Patients undergoing Tadalafil

Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months

Drug: Tadalafil 20 MG

Control Group

Healthy controls without previous surgery of radical prostatectomy.

Interventions

Tadalafil 20 MG DRUG

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.

Also known as: Cialis

Patients undergoing Tadalafil

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 45 years with diagnosis of erectile dysfunction due to surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil. They did not present any ophthalmological disease, diabetes, heart diseases and hypertension.

You may qualify if:

• age older than 45 years
• diagnosis of erectile dysfunction due to surgery of radical prostatectomy
• treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months
• absence of diabetes, heart diseases, hypertension
• absence of drug intake
• absence of vitreoretinal, vascular retinal diseases
• absence of previous ocular surgery and congenital eye diseases.
• absence of errors of refraction
• absence of lens opacities
• absence of low-quality OCT and OCTA images

You may not qualify if:

• age younger than 45 years
• diagnosis of erectile dysfunction due to other causes
• previous treatments before Tadalafil for erectile dysfunction
• presence of diabetes, heart diseases, hypertension
• drug intake
• vitreoretinal and vascular retinal diseases
• previous ocular surgery and congenital eye diseases
• errors of refraction
• lens opacities
• low-quality OCT and OCTA images

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Interventions

Tadalafil

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Gilda Cennamo

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: July 29, 2020
• Study Start: November 1, 2019
• Primary Completion: May 25, 2020
• Study Completion: May 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2019-11

Locations

IT (1)